Help I Have Allergies
FDA Label NDC 49260-611

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Help Remedies, Inc. for the product Help I Have Allergies (NDC 49260-611). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                 Purpose
(in each tablet)

Loratadine 10mg..........................................Antihistamine


Otc - Purpose

Use

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
  • sneezing


Warnings


Warnings

Do not use ifyou have ever had an allergic reaction to this product or any of its ingredients


Ask a doctor before use if you have
  • liver or kidney disease
  • your doctor should determine if you need a different dose
    • When using this product do not take more than directed.Taking more than directed may
    cause drowsiness.

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical
    help right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control
Center right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Dosage & Administration


Directions
  • adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours
  • children under 6 years of age: ask a doctor
  • consumers with liver or kidney disease: ask a doctor

Indications & Usage

Other Information

  • do not use if individual blister is open or torn
  • store between 20-25 degrees celcius (68-77 degrees fahrenheits)
  • protect from excessive moisture
  • use by expiration date on package
  • keep carton. They contain important information.

Inactive Ingredient

Inactive Ingredientscorn starch, lactose monohydrate, magnesium stearate,pregelatinized starch

Otc - Questions

Distributed by Help Remedies,
57 W. 28th St. Fl. 4
New York, NY 10001
www.helpineedhelp.com

Package Label.Principal Display Panel

Helpallergieslabel (Helpallergies)

Helpallergieslabel (Helpallergies)

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